CN102961377A - Method for preparing compound amino acid injection liquid (20AA) - Google Patents
Method for preparing compound amino acid injection liquid (20AA) Download PDFInfo
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- CN102961377A CN102961377A CN201210443226XA CN201210443226A CN102961377A CN 102961377 A CN102961377 A CN 102961377A CN 201210443226X A CN201210443226X A CN 201210443226XA CN 201210443226 A CN201210443226 A CN 201210443226A CN 102961377 A CN102961377 A CN 102961377A
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Abstract
The invention mainly relates to a method for preparing compound amino acid injection liquid (20AA), and belongs to the technical field of medicines. The problems that the amino acid is oxidized and degraded and solution color is deepened because the solution is in contact with oxygen for a long time during preparation and filling are solved by vacuumizing and filling nitrogen during preparation of the injection liquid. In the method, the injection liquid is dissolved in batch or in several times according to the dissolution difficulty of amino acid, so that the problem that the indissolvable amino acid crystal separates out during preparation is solved, and the stability and the quality of the amino acid injection liquid are guaranteed to the maximum limit. The method has the advantages of simple operation, scientific and reasonable process, low cost and low requirement on production equipment.
Description
Technical field
Amino Acid Compound Injection (20AA) is by 20 seed amino acids and formulated kind of high concentration compound branched chain amino acid injection of stabilizing agent, the present invention relates to the preparation method of this medicine.
Background technology
Amino Acid Compound Injection (20AA) belongs to the high branched-chain amino acid injection in the 4th generation, and it brings up to 33% with the ratio of branched-chain amino acid on the basis of third generation amino acid injection balance formula.Branched-chain amino acid has the effect of energy substrate, gluconeogenesis substrate and myogen regulator.It can be all oxidized as the energy outside, can increase the absorption of energy in the situation that does not increase burden of liver, and can be used as the substrate of gluconeogenesis, its in vivo oxidation and alanine a cyclic metabolism mechanism is arranged between synthetic, it is more to produce heat.Every molar leucine, isoleucine, valine produce respectively 42,43,32 molar ATP, can provide a large amount of energy for body.Its characteristics as the energy are that the disconnected oxidation of its first carbon plate produces high-octane phosphate and do not need glutamic acid, and this point has the meaning of particular importance when trauma stress.And mainly metabolism in muscular tissue of BCAA, so wound can reduce the decomposition of the visceral proteins such as muscle protein and liver, promote albumen synthetic, correction negative nitrogen balance that can be more quickly and effectively than equilibrated type aminoacid, stop aminoacid to run off from muscle, thereby effectively suppress the decomposition of muscle protein, aminoacid forms in the scalable serum, makes it the ratio normal relation.
The amino acid transfusion product produce and storage process in, with very easily oxidized behind the contact with air and make the solution flavescence, amino acid content descends.In order to guarantee the stability of product, domestic a lot of enterprises increase aborning the addition of antioxidant or reduce sterilising conditions at present, have larger hidden danger aspect clinical drug safety.
Summary of the invention
The object of the present invention is to provide the preparation method of Amino Acid Compound Injection (20AA), solve in the Freamine Ⅲ preparation process, affect the problem of product quality because aminoacid is unstable.
Amino Acid Compound Injection of the present invention (20AA), contain in every 1000ml injection:
ILE 8.80
L-Leu 13.60
1B acetate 10.60
METHIONINE 1.20
L-Phe 1.60
L-threonine 4.60
L-Trp 1.50
Valine 10.60
L-arginine 8.80
L-Histidine 4.70
Glycine 6.30
ALANINE 8.30
L-PROLINE 7.10
L-ASPARTIC ACID 2.50
L-asparamide 0.55
Pidolidone 5.70
L-ornithine hcl 99 1.66
Serine 3.70
N-acetyl-L-tyrosine 0.86
N-acetyl-L-cysteine 0.80
The preparation method of Amino Acid Compound Injection of the present invention (20AA) is characterized in that comprising following preparation process:
A, take by weighing following component by the formula ratio of every 1000ml Amino Acid Compound Injection:
ILE 8.80
L-Leu 13.60
1B acetate 10.60
METHIONINE 1.20
L-Phe 1.60
L-threonine 4.60
L-Trp 1.50
Valine 10.60
L-arginine 8.80
L-Histidine 4.70
Glycine 6.30
ALANINE 8.30
L-PROLINE 7.10
L-ASPARTIC ACID 2.50
L-asparamide 0.55
Pidolidone 5.70
L-ornithine hcl 99 1.66
Serine 3.70
N-acetyl-L-tyrosine 0.86
N-acetyl-L-cysteine 0.80
B, production process is filled nitrogen process, guarantee that the residual oxygen rate of solution is below 4%;
C, add the water for injection of full dose 50%～90% in the preparation container, heating water for injection drops into first group of aminoacid of recipe quantity to uniform temperature; After the stirring and dissolving, be cooled to uniform temperature, drop into second group of aminoacid of recipe quantity; After the stirring and dissolving, be cooled to uniform temperature, drop into the 3rd group of aminoacid of recipe quantity; Be cooled to suitable temperature, the 4th group of aminoacid stirring and dissolving that drops into recipe quantity is complete;
D, mentioned solution is being filled under the nitrogen condition, adding the solution (concentration of activated carbon is 0.05%～0.2%) that has dissolved the recipe quantity active carbon with an amount of water for injection, insulated and stirred 5 minutes to 20 minutes; After being cooled to room temperature, add to the full amount of water for injection stirring and evenly mixing; Solution takes off charcoal to clear and bright through titanium rod filter circulating filtration;
E, the filled with solution after will filtering enter in the packing container, and packing container carries out evacuation, fills nitrogen and process before and after the fill, and the product after the fill was 105 ℃～121 ℃ sterilizations 5～40 minutes.
Amino Acid Compound Injection of the present invention (20AA) is characterized in that containing stabilizing agent, and stabilizing agent is selected from sodium sulfite, sodium citrate, disodiumedetate, sodium pyrosulfite, sodium hydrogen phosphate or sodium dihydrogen phosphate.
Preparation method of the present invention is characterized in that taking in the production process omnidistance nitrogen filled protection, and the residual oxygen rate of control solution is below 4%.
Preparation method of the present invention is characterized in that being filled with in the production process purity of nitrogen 〉=99.999%.
Preparation method of the present invention is characterized in that aminoacid dissolves employing four components and criticizes the gradation dissolving, and first group of solution temperature is 95 ℃～70 ℃; Second group of solution temperature is 50 ℃～70 ℃; The 3rd group of solution temperature is 40 ℃～60 ℃; The 4th group of solution temperature is 30 ℃～50 ℃.
The specific embodiment
The present invention is described in further detail below in conjunction with the specific embodiment.
Embodiment 1
Prepare as follows Amino Acid Compound Injection:
A, take by weighing following component by the formula ratio of every 1000ml Amino Acid Compound Injection:
ILE 8.80
L-Leu 13.60
1B acetate 10.60
METHIONINE 1.20
L-Phe 1.60
L-threonine 4.60
L-Trp 1.50
Valine 10.60
L-arginine 8.80
L-Histidine 4.70
Glycine 6.30
ALANINE 8.30
L-PROLINE 7.10
L-ASPARTIC ACID 2.50
L-asparamide 0.55
Pidolidone 5.70
L-ornithine hcl 99 1.66
Serine 3.70
N-acetyl-L-tyrosine 0.86
N-acetyl-L-cysteine 0.80
B, production process is filled nitrogen process, guarantee that the residual oxygen rate of solution is below 4%;
C, add the water for injection of full dose 90% in the preparation container, heating water for injection to 95 ℃ drops into first group of aminoacid of recipe quantity; After the stirring and dissolving, be cooled to 75 ℃, drop into second group of aminoacid of recipe quantity; After the stirring and dissolving, be cooled to 60 ℃, drop into the 3rd group of aminoacid of recipe quantity; Be cooled to 50 ℃, the 4th group of aminoacid stirring and dissolving that drops into recipe quantity is complete;
D, mentioned solution is being filled under the nitrogen condition, adding the solution (concentration of activated carbon is 0.1%) that has dissolved the recipe quantity active carbon with an amount of water for injection, insulated and stirred 30 minutes; After being cooled to room temperature, add to the full amount of water for injection stirring and evenly mixing.Solution takes off charcoal to clear and bright through titanium rod filter circulating filtration;
E, the filled with solution after will filtering enter in the packing container, and packing container carries out evacuation, fills nitrogen and process before and after the fill, and the product after the fill was 121 ℃ of moist heat sterilizations 8 minutes.
For the preparation method of Amino Acid Compound Injection of the present invention is described, can produce qualified stable product, according to the Amino Acid Compound Injection of embodiment 1 preparation, in 121 ℃ of moist heat sterilizations 8 minutes.The gained sample is placed under room temperature condition, detects respectively at sampling in 3,6,9,12,18,24 months, measures the projects such as its character, pH value, light transmittance, visible foreign matters, amino acid content.Assay adopts the FDAC amino-acid analyzer to carry out separation determination, the results are shown in Table 1:
The table 1 Amino Acid Compound Injection room temperature investigation result that keeps sample
| Composition | 0 month | 3 months | 6 months | 9 months | 12 months | 18 months | 24 months |
| Character | Little yellow clear liquid | Little yellow is clear and bright | Little yellow is clear and bright | Little yellow is clear and bright | Little yellow is clear and bright | Little yellow is clear and bright | Little yellow is clear and bright |
| PH value | 6.1 | 6.1 | 6.0 | 6.1 | 6.1 | 6.1 | 6.1 |
| Light transmittance | 98.7％ | 98.8％ | 98.6％ | 98.7％ | 98.2％ | 98.1％ | 97.9％ |
| Visible foreign matters | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification |
| Bacterial endotoxin | Up to specification | — | Up to specification | — | — | — | Up to specification |
| Aseptic | Up to specification | — | Up to specification | — | — | — | Up to specification |
| Isoleucine | 98.3 | 98.3 | 98.1 | 97.9 | 97.2 | 97.0 | 96.9 |
| Leucine | 99.2 | 98.4 | 97.5 | 97.4 | 97.7 | 97.1 | 96.8 |
| Lysine acetate | 96.9 | 97.1 | 96.8 | 96.4 | 96.0 | 95.7 | 95.0 |
| Methionine | 98.8 | 98.2 | 98.1 | 97.9 | 97.6 | 96.9 | 96.2 |
| Phenylalanine | 99.7 | 99.3 | 98.7 | 98.6 | 97.4 | 96.7 | 96.1 |
| Threonine | 98.7 | 98.6 | 98.1 | 97.8 | 97.3 | 97.0 | 96.3 |
| Tryptophan | 97.8 | 97.9 | 97.0 | 96.8 | 96.1 | 95.6 | 95.2 |
| Valine | 98.8 | 98.7 | 98.1 | 97.8 | 97.3 | 96.5 | 95.9 |
| Arginine | 97.0 | 97.1 | 97.1 | 96.9 | 96.3 | 95.8 | 95.2 |
| Histidine | 97.8 | 97.5 | 97.4 | 97.3 | 96.7 | 95.9 | 95.2 |
| Alanine | 97.5 | 97.4 | 97.6 | 97.5 | 97.4 | 97.8 | 97.0 |
| Glycine | 96.7 | 95.8 | 95.3 | 94.7 | 93.7 | 93.2 | 92.7 |
| Asparagine | 97.3 | 97.2 | 97.2 | 96.2 | 95.7 | 95.4 | 94.8 |
| Aspartic Acid | 98.9 | 98.6 | 98.5 | 97.9 | 97.8 | 96.9 | 96.2 |
| Glutamic acid | 98.8 | 98.4 | 98.1 | 97.8 | 97.3 | 97.3 | 96.7 |
| Ornithine hcl 99 | 98.0 | 97.8 | 97.8 | 97.1 | 97.0 | 96.7 | 96.2 |
| Proline | 99.5 | 99.2 | 99.3 | 98.9 | 98.5 | 98.3 | 97.2 |
| Serine | 99.4 | 98.7 | 98.3 | 98.3 | 98.0 | 97.4 | 97.1 |
| Acetyl Tyrosine | 100.2 | 99.6 | 99.4 | 98.6 | 98.1 | 97.5 | 97.0 |
| Acetylcysteine | 98.8 | 98.4 | 97.7 | 97.5 | 97.1 | 96.8 | 96.5 |
The result shows that after Amino Acid Compound Injection of the present invention was deposited 24 months at ambient temperature, the indexs such as character, pH value, light transmittance and amino acid content were compared without significant change with 0 month sample.
Embodiment 2
Prepare as follows Amino Acid Compound Injection:
A, take by weighing following component by the formula ratio of every 1000ml Amino Acid Compound Injection:
ILE 8.80
L-Leu 13.60
1B acetate 10.60
METHIONINE 1.20
L-Phe 1.60
L-threonine 4.60
L-Trp 1.50
Valine 10.60
L-arginine 8.80
L-Histidine 4.70
Glycine 6.30
ALANINE 8.30
L-PROLINE 7.10
L-ASPARTIC ACID 2.50
L-asparamide 0.55
Pidolidone 5.70
L-ornithine hcl 99 1.66
Serine 3.70
N-acetyl-L-tyrosine 0.86
N-acetyl-L-cysteine 0.80
B, production process is filled nitrogen process, guarantee that the residual oxygen rate of solution is below 4%;
C, add the water for injection of full dose 90% in the preparation container, heating water for injection to 95 ℃ drops into first group of aminoacid of recipe quantity; After the stirring and dissolving, be cooled to 75 ℃, drop into second group of aminoacid of recipe quantity; After the stirring and dissolving, be cooled to 60 ℃, drop into the 3rd group of aminoacid of recipe quantity; Be cooled to 50 ℃, the 4th group of aminoacid stirring and dissolving that drops into recipe quantity is complete;
D, mentioned solution is being filled under the nitrogen condition, adding the solution (concentration of activated carbon is 0.1%) that has dissolved the recipe quantity active carbon with an amount of water for injection, insulated and stirred 30 minutes; After being cooled to room temperature, add to the full amount of water for injection stirring and evenly mixing; Solution takes off charcoal to clear and bright through titanium rod filter circulating filtration;
E, the filled with solution after will filtering enter in the packing container, and packing container carries out evacuation, fills nitrogen and process before and after the fill, and the product after the fill was 121 ℃ of moist heat sterilizations 12 minutes.
For the preparation method of Amino Acid Compound Injection of the present invention is described, can produce qualified stable product, according to the Amino Acid Compound Injection of embodiment 1 preparation, in 121 ℃ of moist heat sterilizations 12 minutes.The gained sample is placed under 40 ℃ of conditions, detects respectively at sampling in 1,2,3,6 month, measures the projects such as its character, pH value, light transmittance, visible foreign matters, amino acid content.Assay adopts the FDAC amino-acid analyzer to carry out separation determination, the results are shown in Table 2:
40 ℃ of investigation results that keep sample of table 2 Amino Acid Compound Injection
| Composition | 0 month | 1 month | 2 months | 3 months | 6 months |
| Character | Little yellow clear liquid | Little yellow clear liquid | Little yellow clear liquid | Little yellow clear liquid | Little yellow clear liquid |
| PH value | 6.1 | 6.1 | 6.1 | 6.1 | 6.1 |
| Light transmittance (%) | 98.7 | 98.7 | 98.6 | 98.4 | 98.0 |
| Visible foreign matters | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification |
| Bacterial endotoxin | Up to specification | — | — | — | Up to specification |
| Aseptic | Up to specification | — | — | — | Up to specification |
| Isoleucine | 99.2 | 98.5 | 98.5 | 97.2 | 97.0 |
| Leucine | 99.5 | 98.9 | 98.4 | 97.5 | 97.4 |
| Lysine acetate | 99.6 | 99.1 | 98.6 | 98.1 | 97.6 |
| Methionine | 98.3 | 98.0 | 97.5 | 97.2 | 97.2 |
| Phenylalanine | 99.8 | 99.1 | 98.5 | 98.4 | 97.7 |
| Threonine | 98.5 | 98.2 | 97.6 | 97.5 | 96.8 |
| Tryptophan | 99.3 | 98.5 | 98.3 | 98.2 | 97.7 |
| Valine | 99.6 | 98.8 | 97.5 | 97.2 | 97.1 |
| Arginine | 98.9 | 98.2 | 97.5 | 97.4 | 97.0 |
| Histidine | 99.4 | 98.7 | 98.2 | 97.6 | 97.0 |
| Alanine | 98.5 | 98.6 | 97.6 | 97.2 | 96.9 |
| Glycine | 97.8 | 97.8 | 96.8 | 95.9 | 95.6 |
| Asparagine | 98.8 | 98.5 | 98.1 | 97.8 | 96.9 |
| Aspartic Acid | 98.9 | 98.2 | 97.4 | 97.1 | 96.5 |
| Glutamic acid | 98.4 | 97.9 | 97.3 | 96.8 | 96.5 |
| Ornithine hcl 99 | 99.5 | 98.9 | 98.2 | 97.4 | 96.8 |
| Proline | 98.9 | 98.1 | 98.2 | 97.9 | 97.1 |
| Serine | 98.5 | 98.1 | 98.3 | 97.6 | 97.5 |
| The N-acetyl-L-tyrosine | 99.2 | 99.3 | 98.4 | 97.8 | 97.3 |
| N-acetyl-L-cysteine | 98.7 | 98.4 | 98.3 | 97.2 | 96.6 |
The result shows that the equal no significant difference of character, pH value, color, amino acid content of the Amino Acid Compound Injection of preparing is in acceptability limit.The Simultaneous Stabilization investigation is the result show, this product is in long-term put procedure, and the solution homogeneous is clarified, and without the aminoacid crystallization, color is without obvious change.Therefore, the invention solves because feeding intake in a large number and cause the aminoacid dissolubility bad, cause that aminoacid is separated out etc. as temperature in the process for preparation is excessively low.Simultaneously, in that to have solved aminoacid unstable in solution, very easily oxidized, cause the solution colour flavescence to deepen degradation problem under the amino acid content.Simultaneously the present invention requires lower to production equipment, and is easy to producers' operation.
If the content that is not described in detail is arranged in this description, should be the known technology of those skilled in the art, repeat no more herein.
Claims (5)
1.
,The preparation method of Amino Acid Compound Injection (20AA) is characterized in that comprising following preparation process:
A, take by weighing following component by the formula ratio of every 1000ml Amino Acid Compound Injection:
ILE 8.80
L-Leu 13.60
1B acetate 10.60
METHIONINE 1.20
L-Phe 1.60
L-threonine 4.60
L-Trp 1.50
Valine 10.60
L-arginine 8.80
L-Histidine 4.70
Glycine 6.30
ALANINE 8.30
L-PROLINE 7.10
L-ASPARTIC ACID 2.50
L-asparamide 0.55
Pidolidone 5.70
L-ornithine hcl 99 1.66
Serine 3.70
N-acetyl-L-tyrosine 0.86
N-acetyl-L-cysteine 0.80
B, production process is filled nitrogen process, guarantee that the residual oxygen rate of solution is below 4%;
C, add the water for injection of full dose 50%～90% in the preparation container, heating water for injection drops into first group of aminoacid of recipe quantity to uniform temperature; After the stirring and dissolving, be cooled to uniform temperature, drop into second group of aminoacid of recipe quantity; After the stirring and dissolving, be cooled to uniform temperature, drop into the 3rd group of aminoacid of recipe quantity; Be cooled to suitable temperature, the 4th group of aminoacid stirring and dissolving that drops into recipe quantity is complete;
D, mentioned solution is being filled under the nitrogen condition, adding the solution (concentration of activated carbon is 0.05%～0.2%) that has dissolved the recipe quantity active carbon with an amount of water for injection, insulated and stirred 5 minutes to 20 minutes; After being cooled to room temperature, add to the full amount of water for injection stirring and evenly mixing; Solution takes off charcoal to clear and bright through titanium rod filter circulating filtration;
E, the filled with solution after will filtering enter in the packing container, and packing container carries out evacuation, fills nitrogen and process before and after the fill, and the product after the fill was 105 ℃～121 ℃ sterilizations 5～40 minutes.
2. Amino Acid Compound Injection as claimed in claim 1 is characterized in that containing stabilizing agent, and stabilizing agent is selected from sodium sulfite, sodium citrate, disodiumedetate, sodium pyrosulfite, sodium hydrogen phosphate or sodium dihydrogen phosphate.
3. Amino Acid Compound Injection as claimed in claim 1 is characterized in that in the production process, takes omnidistance nitrogen filled protection, and the residual oxygen rate of control solution is below 4%.
4. such as claim 1 or 3 described Amino Acid Compound Injections, it is characterized in that being filled with in the production process purity of nitrogen 〉=99.999%.
5. Amino Acid Compound Injection as claimed in claim 1 is characterized in that aminoacid dissolves employing four components and criticizes the gradation dissolving, and first group of solution temperature is 95 ℃～70 ℃; Second group of solution temperature is 50 ℃～70 ℃; The 3rd group of solution temperature is 40 ℃～60 ℃; The 4th group of solution temperature is 30 ℃～50 ℃.
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| CN106596323A (en) * | 2016-12-13 | 2017-04-26 | 宜昌三峡制药有限公司 | Instant branched-chain amino acid quality standard |
| US10201513B2 (en) | 2016-12-19 | 2019-02-12 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US10596136B2 (en) | 2018-06-20 | 2020-03-24 | Axcella Health Inc. | Compositions and methods for the treatment of fat infiltration in muscle |
| US10660870B2 (en) | 2017-08-14 | 2020-05-26 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
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| CN101627993A (en) * | 2009-08-03 | 2010-01-20 | 上海华源药业（宁夏）沙赛制药有限公司 | Liquid preparation containing fifteen compound amino acids and preparation method thereof |
| CN102440989A (en) * | 2010-10-13 | 2012-05-09 | 四川科伦药物研究有限公司 | Compound amino acid injection and preparation method and detection method thereof |
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| CN101627993A (en) * | 2009-08-03 | 2010-01-20 | 上海华源药业（宁夏）沙赛制药有限公司 | Liquid preparation containing fifteen compound amino acids and preparation method thereof |
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Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106596323A (en) * | 2016-12-13 | 2017-04-26 | 宜昌三峡制药有限公司 | Instant branched-chain amino acid quality standard |
| US10201513B2 (en) | 2016-12-19 | 2019-02-12 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US10238617B2 (en) | 2016-12-19 | 2019-03-26 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US10471034B2 (en) | 2016-12-19 | 2019-11-12 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US11129804B2 (en) | 2016-12-19 | 2021-09-28 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US11602511B2 (en) | 2016-12-19 | 2023-03-14 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US10660870B2 (en) | 2017-08-14 | 2020-05-26 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| US10682325B2 (en) | 2017-08-14 | 2020-06-16 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| US11571404B2 (en) | 2017-08-14 | 2023-02-07 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| US10596136B2 (en) | 2018-06-20 | 2020-03-24 | Axcella Health Inc. | Compositions and methods for the treatment of fat infiltration in muscle |
| US10973793B2 (en) | 2018-06-20 | 2021-04-13 | Axcella Health Inc. | Compositions and methods for the treatment of fat infiltration in muscle |
| US11833127B2 (en) | 2018-06-20 | 2023-12-05 | Axcella Health Inc. | Compositions and methods for the treatment of fat infiltration in muscle |
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Application publication date: 20130313 |